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Sex Drugs: The Second Generation
by Stanley Ducharme, Ph.D.

On March 28, 1998, we ushered in a new era in the sexual revolution. Never in recent memory had a medication received the publicity or popularity of Sidenafil (Viagra). In fact, only the birth control pill had ever come close to prompting the societal and cultural changes brought on by the little blue pill.

Even today after 4 years on the market, over 11,000 prescriptions are written each day by primary care doctors and urologists in the United States alone. No statistics are available for the number of prescriptions sold via the internet but clearly that number is extremely high. For many people, the confidentiality of the internet provides a safe mechanism to obtain prescriptions and to order refills. In addition, Viagra is sold on the “black market” in many cities throughout the US and worldwide.

Statistics for Viagra have demonstrated the wide spread use of the medication. Of those individuals who use Viagra, 58% of men report that they use Viagra each time they are sexually active. Despite the fact that most insurance companies will pay for a maximum of 4 pills per month, the average number of pills taken each month ranges from 5 to 6 doses. In addition, 72% of men using Viagra report that the 100mg dosage is necessary to achieve sufficient rigidly for vaginal penetration while 28% of men report that they typically cut the 100mg pill into two or three pieces. This procedure helps to reduce the cost of each dose. The 25mg dosage is virtually never prescribed.

In spite of its popularity and effectiveness, Viagra has proven to be far from the perfect solution to erectile dysfunction. Many men, such as individuals with severe cardiovascular disease, curvatures of the penis or prostate cancer have found the medication to be ineffective. Complaints about the loss of spontaneity are commonplace. The cost is also prohibitive for many couples. Eating a meal or drinking alcohol tend to reduce its potency. The use of nitroglycerine is contraindicated. Finally, severe headaches, visual disturbances, a stuffy nose and nausea are frequently reported as adverse reactions.

For men with neurological injury or disease, Viagra has been especially effective and generally a welcome addition to the more traditional invasive treatments for erectile dysfunction. The use of injection therapies and the use of the vacuum pump have drastically declined among men with various disabilities. Furthermore, the penile prosthesis, once the treatment of choice for men with spinal cord injury, is rarely ever used except in cases where other systemic medical issues have a significant negative impact on the quality of erections. Despite Viagra’s popularity, public concerns about cost, the lack of insurance coverage and negative side effects make Viagra unobtainable and unusable for many men. Many women are also fearful of potential dangerous side affects that could harm their husband or partner.

With the mounting concerns about the cost and side effects of Viagra, the time has been ripe for competition to Pfizer’s “miracle drug”. Fortunately, we won’t be disappointed. The year 2002 promises to be an exciting year in the sexual arena. This year and in 2003, the second generation “Viagras” will make their debut. As expected, they’ll be better, quicker acting and more effective than what is currently available. Not only can we expect the second-generation pills to be more potent; the pharmaceutical industry even has a few surprises in store for us!

On September 21, 2001, Bayer Pharmaceutical Company applied for FDA approval for it’s new erection medication, Vardenafil. As of this writing the company has not released the brand name for Vardenafil and some last minute name changes have occurred. Regardless of name, the new Bayer product will have many distinct advantages to today’s oral erectile medication and is expected to be released by late 2002.

Bayer promises that Vardenafil will out perform Sidenafil in all the important aspects of safety, effectiveness, cost and speed of onset. For example, while Viagra can potentially facilitate erections for a period of 10 hours, a 10 or 20mg dose of Vardenafil will have a life of approximately 14 hours. Clinical trails of the new medication, which included men with diabetes, have also been encouraging in that the occurrence of side effects is reported to be significantly less than Viagra. This is especially true for the incidence of severe headaches, which in the past has been one of the major negative drawbacks of Pfizer’s Viagra. There is also some speculation that this new erectile medication may not have the serious adverse reaction to nitroglycerine, taken by many men with cardiac conditions. Medical clearance however will continue to be important prior to starting the medication.

Shortly after Vardenafil hits the market, Lilly-ICOS should unveil its new product sometime in 2003. Submitted for FDA approval in June 2001, the Lilly-ICOS product, Tadalafil, is potentially the erection medication that many men have waited for.

Originally scheduled to be released in 2002, the FDA denied approval in May 2002 and currently no dates have been announced. Many people speculate however that once its safety has been firmly documented Tadalafil will debut in 2003 with much fanfare.

Tadalafil may have the potential to revolutionize the whole field of sexually related oral medications. Lilly-ICOS promises it will be worth the wait.
The most astounding feature of Tadalafil is its length of action. According to some reports, this new medication will facilitate a man’s ability to achieve an erection for as long as 36 to 48 hours! Thus in theory, one dose of Tadenafil on a Friday night will provide the potential for the man to achieve a rigid erection anytime he becomes sexually aroused over the entire weekend. Concerns regarding the need to plan for sex and the lack of spontaneity will be virtually eliminated. Issues regarding cost will also be reduced since a single pill will enhance erectile functioning over an extended period of time.

Like Bayer’s Vardenafil, The new Lilly-ICOS product has apparently also addressed issues regarding safety and side effects. In the clinical trials, the incidence of blue vision has been totally eliminated and the occurrence of headaches has also been significantly reduced. Although price has not yet been established for either of these two new medications, both pharmaceutical companies have stated that the prices will be competitive with Pfizer’s Viagra.

In conclusion, although the female pill has yet to be developed, the second generation oral medications for erectile dysfunction are about to make their debut. This will be especially encouraging for the many men who found the results of Viagra to be disappointing or ineffective. It will also provide men with several alternatives that will reduce unwanted side effects, improve spontaneity and potentially reduce the cost associated with the medication. Clearly, these are revolutionary times in the field of sexual medicine and the upcoming months are especially exciting.

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